A Novel Approach to Infantile Spasms
Paused · Phase 3
Conditions studied: Infantile Spasm
In brief
This study proposes to assess the efficacy of Cosyntropin Injectable Suspension, 1 mg/mL compared to vigabatrin. Additionally, this study proposes to determine efficacy of combination therapy of Cosyntropin Injectable Suspension, 1 mg/mL and vigabatrin to monotherapy Cosyntropin Injectable Suspension, 1mg/mL in children with new onset infantile spasms (IS).
Key facts
- Study ID
- NCT03347526
- Run by
- University of Colorado, Denver
- People needed
- 394
- Starts
- 2018-04-19
- Expected to finish
- 2021-08-01
- Last updated by the study team
- 2021-05-27
Who can join
Age: 0 and older, up to 2. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- New onset infantile spasms
- Age > 2 months
- Age< 2 years
- Hypsarrhythmia on video-EEG
- Normal renal function
You may not qualify if…
- Prior treatment given for infantile spasms
- Diagnosis of Ohtahara syndrome or Early Myoclonic Epilepsy
- Absence of hypsarrhythmia
- Inability for the parent or caregiver to provide consent
- Inability for the parent or caregiver to complete seizure diary
- Diagnosis of:
- scleroderma,
- osteoporosis,
- recent systemic fungal infections,
- ocular herpes simplex,
- recent surgery,
- history of or the presence of a peptic ulcer,
- congestive heart failure,
- uncontrolled hypertension
Where it is running
- Children's Hospital Los Angeles — Los Angeles, California, United States
- UCSF Medical Center — San Francisco, California, United States
- University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States
- Children's National Medical Center — Washington D.C., District of Columbia, United States
- Children's Healthcare of Atlanta at Scottish Rite — Atlanta, Georgia, United States
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
- Boston Children's Hospital — Boston, Massachusetts, United States
- C.S. Mott Children's Hospital — Ann Arbor, Michigan, United States
- Mayo Clinic — Rochester, Minnesota, United States
- Columbia University Medical Center — New York, New York, United States
- Montefiore Medical Center — The Bronx, New York, United States
- Atrium Health — Charlotte, North Carolina, United States
- Oregon Health and Science University — Portland, Oregon, United States
- Cook Children's Medical Center — Fort Worth, Texas, United States
Full record on ClinicalTrials.gov
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